Approval for the replacement of the dilution statement from the? Precaution? Section and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e. G. , acetaminophen.
| Device | SYNVISC HYLAN G-F 20 |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Sanofi GENZYME CORP. |
| Date Received | 2007-02-20 |
| Decision Date | 2008-06-09 |
| PMA | P940015 |
| Supplement | S011 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sanofi GENZYME CORP. 50 Binney Street cambridge, MA 02142 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940015 | | Original Filing |
| S051 |
2022-12-16 |
30-day Notice |
| S050 |
2022-09-30 |
Special (immediate Track) |
| S049 |
2021-08-11 |
30-day Notice |
| S048 |
2021-06-01 |
30-day Notice |
| S047 | | |
| S046 |
2020-06-25 |
30-day Notice |
| S045 |
2019-12-05 |
30-day Notice |
| S044 |
2018-12-17 |
30-day Notice |
| S043 |
2018-12-13 |
30-day Notice |
| S042 |
2018-11-30 |
30-day Notice |
| S041 |
2018-05-24 |
135 Review Track For 30-day Notice |
| S040 |
2017-04-17 |
30-day Notice |
| S039 |
2017-02-28 |
30-day Notice |
| S038 |
2016-12-12 |
30-day Notice |
| S037 |
2016-09-29 |
30-day Notice |
| S036 |
2016-03-17 |
30-day Notice |
| S035 |
2015-04-28 |
30-day Notice |
| S034 |
2015-04-24 |
Real-time Process |
| S033 |
2014-07-09 |
Special (immediate Track) |
| S032 |
2014-04-15 |
30-day Notice |
| S031 |
2014-01-14 |
30-day Notice |
| S030 |
2013-11-08 |
30-day Notice |
| S029 |
2013-09-25 |
135 Review Track For 30-day Notice |
| S028 |
2013-08-26 |
135 Review Track For 30-day Notice |
| S027 |
2013-05-31 |
30-day Notice |
| S026 |
2012-05-07 |
30-day Notice |
| S025 |
2011-12-20 |
135 Review Track For 30-day Notice |
| S024 |
2011-12-09 |
30-day Notice |
| S023 |
2011-09-02 |
30-day Notice |
| S022 |
2011-08-05 |
30-day Notice |
| S021 |
2011-06-07 |
30-day Notice |
| S020 |
2011-02-16 |
30-day Notice |
| S019 |
2010-06-09 |
135 Review Track For 30-day Notice |
| S018 |
2010-04-22 |
135 Review Track For 30-day Notice |
| S017 |
2010-01-29 |
30-day Notice |
| S016 | | |
| S015 |
2009-04-16 |
Real-time Process |
| S014 |
2009-02-17 |
30-day Notice |
| S013 |
2008-09-25 |
135 Review Track For 30-day Notice |
| S012 |
2007-06-19 |
Panel Track |
| S011 |
2007-02-20 |
Normal 180 Day Track |
| S010 |
2003-08-15 |
Special (immediate Track) |
| S009 |
2003-02-14 |
Special (immediate Track) |
| S008 |
2003-01-15 |
Real-time Process |
| S007 |
2002-03-29 |
Special (immediate Track) |
| S006 |
2002-03-19 |
Real-time Process |
| S005 |
2000-03-31 |
Real-time Process |
| S004 |
1999-05-03 |
Special (immediate Track) |
| S003 |
1999-04-07 |
Normal 180 Day Track |
| S002 |
1998-10-16 |
Normal 180 Day Track |
| S001 |
1998-09-29 |
Special (immediate Track) |
NIH GUDID Devices